The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.
Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Progression-free survival
Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.
Time frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Objective response
Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.
Time frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Clinical benefit rate
Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.
Time frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
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